Trial Outcomes & Findings for Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone (NCT NCT03304418)
NCT ID: NCT03304418
Last Updated: 2025-04-30
Results Overview
To determine if 20% of ADT naïve men treated with concurrent EBRT and Radium-223 will not require ADT for progression by 15 months.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
15 months
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
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Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radium-223 and Radiotherapy in Hormone-Naïve Men With Oligometastatic Prostate Cancer to Bone
Baseline characteristics by cohort
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=20 Participants
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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20 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 15 monthsTo determine if 20% of ADT naïve men treated with concurrent EBRT and Radium-223 will not require ADT for progression by 15 months.
Outcome measures
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=20 Participants
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
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Count of Participants Requiring Androgen Deprivation Therapy (ADT) Use at 15 Months
|
10 Participants
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SECONDARY outcome
Timeframe: 2 yearsPopulation: 8 of 20 total patients did not begin ADT while on study, so 12 of 20 patients were evaluated for this measure
Determine the hormone-therapy free survival time for men treated with concurrent EBRT and Radium-223 and determine if it is a 30% risk reduction over the SWOG intermittent ADT historic cohort
Outcome measures
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=12 Participants
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
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Median Time From Start of Study Therapy to Start of ADT
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260 Days
Standard Deviation 200.2
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 20 total participants, 10 completed the EPIC questionnaire at the End of Treatment timepoint
To evaluate health related quality of life (QOL) as scored by the 50 item Expanded Prostate Inventory Composite (EPIC) EPIC urinary, bowel, sexual and hormonal domains. EPIC assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better health-related quality of life.
Outcome measures
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=10 Participants
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
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Mean Expanded Prostate Inventory Composite (EPIC) Scores at End of Treatment
Urinary Summary Score
|
74.1 score on a scale
Standard Deviation 17.8
|
|
Mean Expanded Prostate Inventory Composite (EPIC) Scores at End of Treatment
Bowel Summary Score
|
89.1 score on a scale
Standard Deviation 10.9
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Mean Expanded Prostate Inventory Composite (EPIC) Scores at End of Treatment
Sexual Summary Score
|
12.4 score on a scale
Standard Deviation 9.8
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Mean Expanded Prostate Inventory Composite (EPIC) Scores at End of Treatment
Hormonal Summary Score
|
81.9 score on a scale
Standard Deviation 17.5
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SECONDARY outcome
Timeframe: 6 monthsPopulation: Of the 20 total participants, 10 completed the EPIC questionnaire at the End of Treatment timepoint
To evaluate health related quality of life (QOL). The PROMIS-29 (Patient-Reported Outcomes Measurement Information System) will be used to assess general function and well-being. The raw score for each PROMIS instrument is converted to a T-score on a scale of 0-100. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10. A higher PROMIS T score represents more of the concept being measured. For negatively worded concepts like Anxiety, a T score of 60 is one SD worse than average. By comparison, an Anxiety T score of 40 is one SD better than average. However, for positively worded concepts like Physical Function Mobility, a T score of 60 is one SD better than average while a T score of 40 is one SD worse than average.
Outcome measures
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=10 Participants
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
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Mean PROMIS-29 Scores at End of Treatment
Pain Interference
|
53.5 T-scores
Standard Deviation 9.3
|
|
Mean PROMIS-29 Scores at End of Treatment
Depression/Sadness
|
44.7 T-scores
Standard Deviation 6.1
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|
Mean PROMIS-29 Scores at End of Treatment
Physical Function
|
46.9 T-scores
Standard Deviation 11.2
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|
Mean PROMIS-29 Scores at End of Treatment
Fatigue
|
47 T-scores
Standard Deviation 10.1
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|
Mean PROMIS-29 Scores at End of Treatment
Anxiety/Fear
|
45.2 T-scores
Standard Deviation 6.6
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|
Mean PROMIS-29 Scores at End of Treatment
Sleep Disturbance
|
49.1 T-scores
Standard Deviation 7.7
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|
Mean PROMIS-29 Scores at End of Treatment
Satisfaction with Social Roles and Activities
|
49.8 T-scores
Standard Deviation 7.7
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SECONDARY outcome
Timeframe: 2 yearsPopulation: Of 20 evaluable participants, two experienced a skeletal related event.
Documentation of complications associated with bone metastases and may include (but not limited to) fractures, spinal cord compression, bone pain, and hypercalcemia.
Outcome measures
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=2 Participants
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
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Evaluate Time to First Skeletal Related Event (SRE)
|
554.5 Days
Standard Deviation 154.9
|
SECONDARY outcome
Timeframe: 2 years, assessed at every visit in that time periodThis outcome measure will report the mean time elapsed from baseline PSA to PSA to double in value. Participants were followed for 24 months from the initiation of study treatment. PSA doubling time was censored at 24 months.
Outcome measures
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=20 Participants
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
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Evaluate the PSA Doubling Time
|
19.32 months
Standard Deviation 8.26
|
SECONDARY outcome
Timeframe: 2 years after study enrollmentThis outcome measure will report the overall survival at 2 years. Patients were followed for survival for two years after study enrollment. Patients who refused follow-up were censored at their off-study date.
Outcome measures
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=20 Participants
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
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Evaluate Overall Surival
|
22.98 month
Standard Deviation 4.55
|
Adverse Events
Radium Ra 223 Dichloride and Radiation, All Patients
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=20 participants at risk
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
Other adverse events
| Measure |
Radium Ra 223 Dichloride and Radiation, All Patients
n=20 participants at risk
Radium Ra 223 Dichloride: Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
Radiation: All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
* Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
* Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
* Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
* Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)
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|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
2/20 • Number of events 2 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Blood and lymphatic system disorders
Anemia
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
4/20 • Number of events 4 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Gastrointestinal disorders
Bloating
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
4/20 • Number of events 5 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Nervous system disorders
Cognitive disturbance
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Gastrointestinal disorders
Constipation
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
4/20 • Number of events 4 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
General disorders
Edema limbs
|
10.0%
2/20 • Number of events 2 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.0%
1/20 • Number of events 2 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Gastrointestinal disorders
Esophagitis
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
General disorders
Fatigue
|
70.0%
14/20 • Number of events 16 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
General disorders
Flu like symptoms
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Injury, poisoning and procedural complications
Fracture
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Nervous system disorders
Headache
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Renal and urinary disorders
Hematuria
|
15.0%
3/20 • Number of events 3 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Investigations
Lymphocyte count decreased
|
5.0%
1/20 • Number of events 3 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Gastrointestinal disorders
Nausea
|
25.0%
5/20 • Number of events 6 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
General disorders
Pain
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Nervous system disorders
Paresthesia
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Investigations
Platelet count decreased
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Nervous system disorders
Presyncope
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Renal and urinary disorders
Renal and urinary disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
10.0%
2/20 • Number of events 2 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
10.0%
2/20 • Number of events 2 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Number of events 2 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Renal and urinary disorders
Urinary incontinence
|
10.0%
2/20 • Number of events 2 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Renal and urinary disorders
Urinary urgency
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Ear and labyrinth disorders
Vertigo
|
5.0%
1/20 • Number of events 2 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Investigations
Weight loss
|
5.0%
1/20 • Number of events 1 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
|
Investigations
White blood cell decreased
|
10.0%
2/20 • Number of events 3 • The collection of all adverse events will begin after the first dose of study treatment and end 30 days after the last dose of study treatment. The collection of treatment-related adverse events will continue until the last study visit (or until new cancer treatment is initiated, if sooner).
|
Additional Information
Clinicaltrials.gov and CTRP Specialist
Huntsman Cancer Institute/University of Utah
Phone: 8012136215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place